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Agenda

Align Global Data Collection and Analysis Systems • Ensure Cross Functional Collaboration and Preparedness • Achieve Accurate and Timely Reporting

November 7, 2018
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

Wednesday, November 7, 2018

7:15

Registration and Continental Breakfast

8:15

Chairperson’s Welcome and Opening Remarks

Susan Welsh
Chief Safety Officer
CSL Behring

Regulatory Spotlight

8:30

Examine Evolving Global Pharmacovigilance Regulations and the Impact on Audit and Inspection Readiness

Shelley Gandhi, BSc (Hons). MSc
Strategic Advisor
NDA Group AB

9:15

Good Pharmacovigilance Practices for Inspections — The Canadian Perspective

Katarina Susnjar
Compliance Specialist
Health Canada

Optimize Your Organizational Structure and
Management Practices for PV Audits and Inspections

9:35

Quality Management Systems — What’s in it for Pharmacovigilance?

Marissa Fernandez, MD
Pharmacovigilance Manager
Baxter Corporation

10:15

Networking and Refreshment Break

10:45

Best Practices for Working with Inspectors —
A “How To” Guide to Managing the Important Details

Amanda B. Parrish, PhD, RAC
Director of Regulatory Affairs and Quality
Duke University School of Medicine

11:30

ROUNDTABLE DISCUSSIONS Design Internal Collaboration Strategies to Overcome Barriers to Audit and Inspection Preparation

FACILITATOR:

Susan Welsh
Chief Safety Officer
CSL Behring

12:15

Networking Luncheon

Improve Data Capture, Management, Reporting and
Related Inspection Processes

1:30

Overcome the Challenge of Managing PV Agreements Across the Enterprise and Between Third Parties

Janet Auerbach
Safety Systems Project Manager
CSL Behring

Andrew Bond
Global PV Excellence and Compliance Specialist,
Global Clinical Safety & Pharmacovigilance (GCSP),
CSL Behring

2:15

Standardize Processes for Sourcing and Managing Social Media Signal Data in Preparation for Audits

Jaylaxmi Nalawade
Associate Director - Pharmacovigilance and REMS
Lupin Pharmaceuticals

2:45

Networking and Refreshment Break

3:15

Ensure Inspection Readiness Through Mock Inspections

Deanna Montes de Oca, PharmD
Director, PV Operations, Clinical Safety and Pharmacovigilance
Otsuka Pharmaceutical Development and Commercialization, Inc.

4:00

Global Manufacturing Pharmacovigilance —
Creating a Systematic Interface Between Pharmacovigilance and Quality Assurance to Address Inspection Requirements

Christoph Hoeck, PhD
Global Manufacturing Site Pharmacovigilance Representative
CSL Behring

4:45

Chairperson’s Closing Remarks

Susan Welsh
Chief Safety Officer
CSL Behring

5:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

Wednesday, November 7, 2018

7:15

Registration and Continental Breakfast

8:15

Chairperson’s Welcome and Opening Remarks

Susan Welsh
Chief Safety Officer
CSL Behring

Regulatory Spotlight

8:30

Examine Evolving Global Pharmacovigilance Regulations and the Impact on Audit and Inspection Readiness

Shelley Gandhi, BSc (Hons). MSc
Strategic Advisor
NDA Group AB

9:15

Good Pharmacovigilance Practices for Inspections — The Canadian Perspective

Katarina Susnjar
Compliance Specialist
Health Canada

Optimize Your Organizational Structure and
Management Practices for PV Audits and Inspections

9:35

Quality Management Systems — What’s in it for Pharmacovigilance?

Marissa Fernandez, MD
Pharmacovigilance Manager
Baxter Corporation

10:15

Networking and Refreshment Break

10:45

Best Practices for Working with Inspectors —
A “How To” Guide to Managing the Important Details

Amanda B. Parrish, PhD, RAC
Director of Regulatory Affairs and Quality
Duke University School of Medicine

11:30

ROUNDTABLE DISCUSSIONS Design Internal Collaboration Strategies to Overcome Barriers to Audit and Inspection Preparation

FACILITATOR:

Susan Welsh
Chief Safety Officer
CSL Behring

12:15

Networking Luncheon

Improve Data Capture, Management, Reporting and
Related Inspection Processes

1:30

Overcome the Challenge of Managing PV Agreements Across the Enterprise and Between Third Parties

Janet Auerbach
Safety Systems Project Manager
CSL Behring

Andrew Bond
Global PV Excellence and Compliance Specialist,
Global Clinical Safety & Pharmacovigilance (GCSP),
CSL Behring

2:15

Standardize Processes for Sourcing and Managing Social Media Signal Data in Preparation for Audits

Jaylaxmi Nalawade
Associate Director - Pharmacovigilance and REMS
Lupin Pharmaceuticals

2:45

Networking and Refreshment Break

3:15

Ensure Inspection Readiness Through Mock Inspections

Deanna Montes de Oca, PharmD
Director, PV Operations, Clinical Safety and Pharmacovigilance
Otsuka Pharmaceutical Development and Commercialization, Inc.

4:00

Global Manufacturing Pharmacovigilance —
Creating a Systematic Interface Between Pharmacovigilance and Quality Assurance to Address Inspection Requirements

Christoph Hoeck, PhD
Global Manufacturing Site Pharmacovigilance Representative
CSL Behring

4:45

Chairperson’s Closing Remarks

Susan Welsh
Chief Safety Officer
CSL Behring

5:00

Close of Conference